The Women In Steady Exercise Research (WISER) Survivor Trial

This study is ongoing, but not recruiting participants.

Sponsor:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01515124

First Posted: January 23, 2012

Last Update Posted: February 15, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The purpose of this study is to test the effects of these interventions on lymphedema outcomes, breast cancer recurrence and quality of life.

The cost analysis sub-study - will assess the cost-effectiveness of conducting the WISER Survivor interventions and also model the impact of the WISER Survivor interventions over an extended time frame.

The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions.

Behavioral: Exercise Intervention

The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.

Experimental: Weight loss only

The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact.

Behavioral: Weight Loss Intervention

The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.

Experimental: Exercise and Weight loss combined

Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program.

Behavioral: Exercise Intervention

The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.

Behavioral: Weight Loss Intervention

The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

breast cancer survivor

overweight or obese (BMI of 25 or greater)

must have breast cancer related lymphedema

at least 2 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis

the eligible age range will have no lower or upper limit.

currently free of cancer

Exclusion Criteria:

medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims

inability to walk for 6 minutes unaided

extremely obese (body mass index greater or equal to 50 kg/m2)

plans for additional (e.g. curative or reconstructive) surgery during the study period

self-report of weight-lifting within the past year

already engaging in 3 or more times weekly aerobic activity of moderate intensity

planning to move away from the area over the next year

current use of weight loss medication (OTC or prescription)

self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)

weight loss of greater than 10 % in the past 3 months

history of bariatric surgery

women who are pregnant

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515124

Locations

United States, Pennsylvania

The University of Pennsylvania TREC Survivorship Center/ Perelman School of Medicine

Consensus Document on the Management of Cellulitis in Lymphoedema. British Lymphology Society and the Lymphedema Support Network, 2007. (Accessed October 26, 2009, at http://www.lymphoedema.org/lsn/consensus_on_cellulitis_dec_06.pdf.)